This is the first large registry to tackle the issue of unexpected cardiac arrest and death during elective PCI, the authors note.

"When I was at last year's EuroPCR, I thought it was very striking that during many complication sessions apparently no patients died," he said. "We don't like talking about fatal complications and we don't publish on the topic, but I think it's very important. This was actually the reason to conduct a large multicenter European registry on this topic."

More than half (55%) the patients had a SYNTAX 1 score below 20 and 52% had a normal left ventricular ejection fraction (LVEF).

The cause of cardiac arrest was most commonly classified as a technical complication (39%) or cumulative ischemia (32%); other causes were acute stent thrombosis (7%), no reflow (7%), and miscellaneous (13%).

Although patients with a low SYNTAX score or normal ejection fraction typically arrested because of a technical complication, the proportion arresting because of cumulative ischemia rose with increasing SYNTAX score and worsening ejection fraction. Prognosis was worse if the LVEF was less than 35% and the SYNTAX score more than 30; mortality was inversely related to both.

Among the 29 patients who underwent salvage coronary artery bypass graft surgery, mortality was quite high, at 62% (n = 18). And, "remarkably, all patients who were referred for surgery with a coronary perforation died [n = 8], so this might be a clue to do everything you can to fix it on the table," Ameloot said.

Mortality with bail-out mechanical support was also remarkably high in this cohort, whether using an intra-aortic balloon pump (53%; n = 62), veno-arterial extracorporeal membrane oxygen (43%; n = 9), or the Impella device (100%; n = 7), he noted.

A Paucity of Data

During a discussion of the results, panelist Tom Mabin, MD, Vergelegen Mediclinic, Franschoek, South Africa, who is a scientific advisory board member for EuroPCR, said the study reflects the value of a well-kept database and provides "very interesting data."

"I don't think there's anything outstandingly surprising but it does support some of the concepts we have and certainly you can see the value in avoiding complications," he said. "Well done."

Panelist Nick E.J. West, MD, Royal Papworth Hospital, Cambridge, United Kingdom, also called the data "very interesting," but nevertheless said the "event rate feels a bit higher than I would think in my practice." In the BCIS-1 study, he said, the mortality risk in the United Kingdom for an elective angioplasty is "0.14%, or more like one in a 1000 than one in 700. Did you look at any of the predictors of these outcomes?"

To do that, Ameloot said a database of patients who didn't die on the table would be needed as a comparator group and suggested that event rates might be higher because the procedures were performed at high-volume centers treating the most complex cases.

Panelist Khaled F. Al-Shaibi, MD, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia, said high-risk PCI, in which cumulative ischemia is common, is identifiable ahead of time, unlike death in a low-risk PCI patient. Still, bailout surgery and bailout mechanical support are of limited value and carry a very high mortality.

"There is a very big discrepancy in the uptake of mechanical support in high-risk PCI, say, in North American compared with Europe, so how do you see that changing?" he asked.

Ameloot replied that besides the BCIS-1 and PROTECT II trials, which he described as methodologically flawed, "there is a huge lack of data," including data on the Impella, which is the device most often used for this indication.

"If you look at PROTECT II, the number-needed-to-treat to prevent one event is around nine, so if you multiply this by the cost, then it is way too expensive to use in patients," he said. "I think patient selection is paramount and, as we showed, patients with a SYNTAX score above 30 and an ejection fraction below 35% most often died because of cumulative ischemia on the table. I think this is valuable information for future patient selection in similar trials."

Commenting further to theheart.org | Medscape Cardiology panelist Mabin, said the study provides a great deal of valuable data that will likely spur further analysis.

"We need more details in terms of what is causing this and why, and what sort of precautions should be taken," he said. "This is the first presentation of the data. I think people will feed on this now and you'll see next year there will be a whole other subanalysis going on. People will be looking more carefully."

Ameloot, Mabin, and West report no relevant conflicts of interest.

Congress of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2019. Presented May 23, 2019.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

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